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Sexual DysfunctionPhase 3NCT00413764

Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

A Phase 3 study testing tibolone and estradiol-norethisterone in people with Sexual Dysfunction, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction. This is important because there is currently no approved treatment of libido problems in postmenopausal women. Read more about this study

Who is it for?
Ages 48 to 68 years, women only
Conditions the study is for
Sexual Dysfunction
What is being tested?
tibolone and estradiol-norethisterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
No sites listed yet
Study dates
23 Mar 2004to 15 Nov 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 68 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physically and mentally healthy postmenopausal women, >=48 and <=68 years of age, with an intact uterus.
  • Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner problems. The decreased sexual functioning was to result in sexually related personal distress as confirmed by the FSDS (score =15).
  • An affirmative answer was to be given to the following questions: (a) In previous years did you find sexual activity satisfying? (b) Has there been a decline in your satisfaction with sexual activity? (c) Are you satisfied with your partner as a friend?
  • All subjects were to have an established sexual relationship of at least 6 months duration prior to screening.
  • Women were to be sexually active.
  • Normal mammography within 6 months prior to randomization.
  • Body mass index >18 and <=32 kg/m2.
  • Voluntary written informed consent

Who cannot join

  • Any unexplained abnormal uterine bleeding
  • Double layer endometrial thickness >4 mm
  • Tibolone or transdermal E2/NETA use within 3 months prior to screening
  • Progestogen implants or injections and estrogen/progestogen injectable therapy within 6 months prior to screening
  • Use of intra-uterine progestogen
  • Unsuccessful previous treatment with androgens or compounds known to enhance androgenic activity
Show all 32Show fewer
  • Current successful treatment with androgens, without applying the applicable washout period of 3 months prior to screening
  • Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (previous low dose vaginal estrogen-only applications are allowed)
  • Use of anti -androgens within the preceding 5 years prior to screening.
  • Women with significant organic disorder of sexual dysfunction or a partner with sexual dysfunction
  • Women who had early onset sexual dysfunction (>15 years prior to menopause)
  • Women suffering from androgenic alopecia, acne or hirsutism
  • Women suffering from illnesses influencing sexuality
  • Women using medication influencing sexuality
  • Moderate to severe depression
  • Current or prior use of antidepressant within 8 weeks prior to screening
  • Major gynecological surgery in the preceding 3 months
  • Any serious disease or disorder; or any endocrine disorder with systemic disease which would have impaired overall health and well being (controlled hypo/hyperthyroidism and diabetes mellitus Type II was allowed)
  • History or presence of severe psychiatric illness and/or any addictions to drugs, medication or alcohol in the past 3 years
  • Diseases for which exogenous hormonal steroids were contraindicated.
  • History or presence of any malignancy, except successfully treated non-melanoma skin cancers
  • History or presence of cardiovascular or cerebrovascular conditions, thrombosis or thromboembolic disorders
  • History or presence of liver, gallbladder or renal disease, epilepsy or classical migraine headaches
  • Uncontrolled hypertension
  • Women with abnormal cervical smear results
  • History or presence of breast cancer, suspicious breast lump or mammographic abnormality
  • Known hypersensitivity to any of the ingredients of the trial medication.
  • Non-compliance with the screening diary
  • Current use of raloxifene, clonidine, veralipride, phytoestrogen extracts
  • Drugs known to interfere with the pharmacokinetics of the steroids
  • Use of investigational drugs within the past 60 days
  • Any disease or condition that was clinically relevant and which, in the opinion of the investigator, would have jeopardized the subject's well being during the course of the trial

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double Dummy Trial to Compare the Effects Tibolone and Transdermal Continuous Combined Estradiol/Norethisterone on Sexual Desire and Arousal in Postmenopausal Women With Sexual Dysfunction

Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction. This is important because there is currently no approved treatment of libido problems in postmenopausal women. Therefore, the primary aim of this study was to compare the effects of tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual dysfunction.

Being tested
tibolone, estradiol-norethisterone
Medical subject headings
Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tiboloneDrug

    Also called Livial®

    tibolone (2.5 mg) over 24 weeks

  • estradiol-norethisteroneDrug

    Also called Combipatch®, Estalis®

    transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks

Study groups in NCT00413764
Study groupRoleWhat they receive
1Experimentaltibolone
Receives: Drug: tibolone
2Active comparatortransdermal continuous combined E2-NETA (estradiol-norethisterone)
Receives: Drug: estradiol-norethisterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the effect of tibolone (2.5 mg) to transdermal E2/NETA (50/140 mcg) on the vaginal bleeding and spotting rate in healthy postmenopausal women with sexual dysfunction.

    Measured: Week 13-24 of the in treatment period

  2. Compare the effect of tibolone to E2/NETA on sexual functioning in healthy postmenopausal women with sexual dysfunction.

    Measured: Week 8-12 and Week 20-24 of the in-treatment period.

Secondary outcomes (1)

  1. Compare the effects of tibolone to E2/NETA on the frequency of satisfactory sexual events, the frequency of sexual fantasies and subjective arousal, scores on the FSFI, FSDS, WHQ and endocrine parameters

    Measured: Week 8-12 and Week 20-24 of the in-treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2006 (estimated)
  2. Study start23 Mar 2004
  3. Primary completion15 Nov 2005
  4. Study completion15 Nov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413764
Sponsor's protocol ID
P06089
Other IDs
C-1774
Status last verified
Feb 2022
First submitted
19 Dec 2006
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Nijland EA, Weijmar Schultz WC, Nathorst-Boos J, Helmond FA, Van Lunsen RH, Palacios S, Norman RJ, Mulder RJ, Davis SR; LISA study investigators. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008 Mar;5(3):646-56. doi: 10.1111/j.1743-6109.2007.00726.x.

    PubMed 18304284

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tibolone and estradiol-norethisterone in people with Sexual Dysfunction, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the effect of tibolone (2.5 mg) to transdermal E2/NETA (50/140 mcg) on the vaginal bleeding and spotting rate in healthy postmenopausal women with sexual dysfunction. (time frame: Week 13-24 of the in treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00413764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

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